Study of Food Effects of VV913 Capsules in Chinese Healthy Volunteers
ConditionHealthy Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorVigonvita Life Sciences
About this trial
This study is a single-center, randomized, open label, 3×3 crossover design to assess the high-fat meal and the standard meal effects on PK of a single oral dose of VV913 in healthy adult volunteers.
Eligibility criteria
Qualifiers
Aged 18 to 45 years old, males ;
Males weight no less than 50 kg, with body mass index of 19 to 26 kg/m²;
Vital signs examination, physical examination, laboratory examination ,Chest X-ray are normal or considered abnormal without clinical significance by the investigator;
Participants who are willing to take proper contraceptive methods during the study and within 3 months after the the last administration;
Disqualifiers
Participants with hypersensitivity to preparation or any of the excipients;
Participants with allergic constitution (such as asthma, urticaria, eczematous dermatitis and other allergic diseases), or have a history of drug or food allergy;
Participants with central nervous system, cardiovascular system, gastrointestinal, respiratory system, urinary, hematologic, or metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials; Participants with a history of gastrointestinal conditions that may impair drug absorption (e.g., gastrectomy or small intestine resection, atrophic gastritis, gastrointestinal ulcers or perforations/fistulas, gastrointestinal bleeding, or obstruction);
Participants with a history of surgery within 3 months before screening, or have not recovered from surgery, or have an expected surgical plan during the trial;
Trial design
Treatments tested in this trial
- VV913
- VV913
- VV913
Treatment groups
12 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov